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LMAT > SEC Filings for LMAT > Form 10-Q on 13-Aug-2008All Recent SEC Filings

Show all filings for LEMAITRE VASCULAR INC | Request a Trial to NEW EDGAR Online Pro

Form 10-Q for LEMAITRE VASCULAR INC


13-Aug-2008

Quarterly Report


Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

This Quarterly Report on Form 10-Q contains forward-looking statements (within the meaning of the federal securities law) that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this Quarterly Report on Form 10-Q regarding our strategy, future operations, future financial position, future net sales, projected costs, projected expenses, prospects, and plans and objectives of management are forward-looking statements. The words "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We have based these forward-looking statements on our current expectations and projections about future events. Although we believe that the expectations underlying any of our forward-looking statements are reasonable, these expectations may prove to be incorrect, and all of these statements are subject to risks and uncertainties. Should one or more of these risks and uncertainties materialize, or should underlying assumptions, projections, or expectations prove incorrect, actual results, performance, or financial condition may vary materially and adversely from those anticipated, estimated, or expected. We have identified below some important factors that could cause our forward-looking statements to differ materially from actual results, performance, or financial conditions:

• the unpredictability of our quarterly net sales and results of operations;

• the ability to keep pace with a rapidly evolving marketplace and to develop or acquire and then successfully market new and enhanced products;

• our ability to successfully identify, acquire, and integrate new products, businesses, and technologies and realize expected benefits;

• a highly competitive market for medical devices;

• the effect of a disaster at any of our manufacturing facilities;

• the loss of any significant suppliers, especially sole-source suppliers;

• the loss of any distributor or any significant customer, especially in regard to any product that has a limited distributor or customer base;

• our ability to adequately grow our operations and attain sufficient operating scale;

• our ability to obtain adequate profit margins;

• our ability to effectively protect our intellectual property and not infringe on the intellectual property of others;

• possible product liability lawsuits and product recalls;

• inadequate levels of third-party reimbursement to healthcare providers;

• our ability to initiate, complete, or achieve favorable results from clinical studies of our products;

• our ability to obtain and maintain U.S. and foreign regulatory clearance for our products and our manufacturing operations;

• our ability to raise sufficient capital when necessary or at satisfactory valuations;

• loss of key personnel; and

• other factors discussed elsewhere in this Quarterly Report on Form 10-Q.

For more information regarding these and other uncertainties and factors that could cause our actual results to differ materially from what we have anticipated in our forward-looking statements, or that otherwise could materially adversely affect our business, financial condition, or operating results, see our annual report on Form 10-K for the fiscal year ended December 31, 2007, under the heading "Part I - Item 1A. Risk Factors" and those risk factors included under the heading "Part II - Item 1A. Risk Factors" in this quarterly report.


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All forward-looking statements included in this report are expressly qualified in their entirety by the foregoing cautionary statements. We wish to caution readers not to place undue reliance on any forward-looking statement that speaks only as of the date made and to recognize that forward-looking statements are predictions of future results, which may not occur as anticipated. Actual results could differ materially from those anticipated in the forward-looking statements and from historical results, due to the uncertainties and factors described above, as well as others that we may consider immaterial or do not anticipate at this time. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. Our expectations reflected in our forward-looking statements can be affected by inaccurate assumptions we might make or by known or unknown uncertainties and factors, including those described above. The risks and uncertainties described above are not exclusive, and further information concerning us and our business, including factors that potentially could materially affect our financial results or condition, may emerge from time to time. We assume no obligation to update, amend, or clarify forward-looking statements to reflect actual results or changes in factors or assumptions affecting such forward-looking statements. We advise you, however, to consult any further disclosures we make on related subjects in our annual reports on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K we file with or furnish to the Securities and Exchange Commission.

The following discussion and analysis should be read in conjunction with our consolidated financial statements and the related notes included in this report and our audited consolidated financial statements and the related notes contained in our Annual Report on Form 10-K for the year ended December 31, 2007, as filed with the Securities and Exchange Commission.

Unless the context requires otherwise, references to "LeMaitre Vascular," "we," "our," and "us" in this Quarterly Report on Form 10-Q refer to LeMaitre Vascular, Inc. and its subsidiaries.

LeMaitre, AnastoClip, EndoFit, Expandable LeMaitre Valvulotome, Flexcel, Glow 'N Tell, Grice, Inahara-Pruitt, InvisiGrip, LeverEdge, MollRing Cutter, NovaSil, OptiLock, Periscope, Pruitt, Pruitt-Inahara, Reddick, TT, UniFit, VascuTape, VCS, and the LeMaitre Vascular logo are registered trademarks of LeMaitre Vascular, and Albograft, aSpire, Biomateriali, EndoHelix, EndoRE, F3, Martin, and TAArget are unregistered trademarks of LeMaitre Vascular. This Quarterly Report on Form 10-Q also includes the registered and unregistered trademarks of other persons.

Overview

We are a medical device company that develops, manufactures, and markets medical devices and implants for the treatment of peripheral vascular disease. Our principal product offerings are sold throughout the world, primarily in the United States, the European Union, and, to a lesser extent, Japan. We estimate that the annual worldwide market addressed by our 14 current product lines exceeds $1 billion and that the annual worldwide market for all peripheral vascular devices exceeds $3 billion and is growing at 8 percent per year. We have used acquisitions as a primary means of further accessing the peripheral vascular device market, and we expect to continue to pursue this strategy in the future. We currently manufacture our product lines in our Burlington, Massachusetts, headquarters with the exception of the LeverEdge Contrast Injector (acquired in April 2007) and the Vascular Architects products (acquired in September 2007), for which the manufacturing is currently outsourced. In addition, our Albograft vascular grafts (acquired in December 2007), are manufactured at our facility in Brindisi, Italy.

Our products are used by vascular surgeons who treat peripheral vascular disease through both open surgical methods and more recently adopted endovascular techniques. Unlike interventional cardiologists and interventional radiologists, who are not typically certified to perform open surgical procedures, vascular surgeons can perform both open surgical and minimally invasive endovascular procedures, and are therefore uniquely positioned to provide patients with a wider range of treatment options.

We believe that the purchasing volume of the vascular surgeon will increase and that the changing product needs of the vascular surgeon present us with attractive opportunities to sell new devices. As a result, we have sought out and acquired new products and businesses that address these needs, such as our acquisition of the contrast injector in April 2007, the remote endarterectomy suite of products in September 2007, our signing of a three-year distribution agreement as the exclusive distributor of the Endologix Powerlink System in 11 European countries, which commenced January 1, 2007, and the acquisition of a line of polyester vascular grafts in December 2007.


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Below is a listing of our product lines and product categories:

• Our Endovascular & Dialysis Access product category includes our TAArget Thoracic Stent Graft, UniFit Abdominal Stent Graft, VascuTape Radiopaque Tape, AnastoClip Vessel Closure System, LeverEdge Contrast Injector, and aSpire Covered Stent. We also report our distribution sales of the Endologix Powerlink System within this product category.

• Our Vascular product category includes our Expandable LeMaitre Valvulotome; Flexcel, Pruitt-Inahara, and Pruitt F3 Carotid Shunts; InvisiGrip Vein Stripper; LeMaitre Balloon Catheters; five remote endarterectomy products, which include our Martin Dissector, Schubart Periscope, EndoHelix, MollRing Cutter, and Ring Dissector; and our Albograft line of polyester prosthetic grafts.

• Our General Surgery product category includes our Reddick Cholangiogram Catheter and its accessories and our OptiLock Implantable Port.

• Our OEM category includes sales of a dacron product to a cardiac device manufacturer.

We evaluate the sales performance of our various product lines utilizing criteria that vary based upon the position of each product line in its expected life cycle. For established products, we typically review unit sales and selling prices. For faster growing products, we typically also focus on new account generation and customer retention.

Our business strategies include the following:

• the maintenance or expansion of our sales teams in North America, Europe, and Japan;

• the addition of complementary products through further acquisitions;

• the updating of existing products and the introduction of new products through research and development; and

• the introduction of our products in new markets via regulatory approvals.

We are currently pursuing all of these strategies.

To assist us in evaluating our business strategies, we regularly monitor long-term technology trends in the peripheral vascular device market. Additionally, we consider the information obtained from discussions with the medical community in connection with the demand for our products, including potential new product launches. We also use this information to help determine our competitive position in the peripheral vascular device market and our manufacturing capacity requirements.

We sell our products primarily through a direct sales force. Our sales force was comprised of 50 sales representatives in North America, the European Union, and Japan as of June 30, 2008. We also sell our products through a network of distributors in various countries outside of the United States and Canada. In 2007, approximately 90% of our net sales were direct-to-hospital. For the six-months ended June 30, 2008, approximately 87% of our net sales were direct-to-hospital.

Our worldwide headquarters are in Burlington, Massachusetts. Our international operations are headquartered in Sulzbach, Germany. We also have sales offices located in Tokyo, Japan, and Rome, Italy, and a manufacturing facility in Brindisi, Italy. For the six months ended June 30, 2008, approximately 46% of our net sales were denominated in currencies other than the U.S. dollar. Accordingly, our results of operations are influenced by changes in currency exchange rates. Increases or decreases in the value of the U.S. dollar, as compared to other currencies in which our net sales are denominated, will directly affect our reported results as we translate those currencies into U.S. dollars for reporting purposes.

Our strategy for growing our business includes the acquisition of complementary product lines and companies and occasionally the discontinuance of products or activities that are no longer complementary. These actions may affect the comparability of our financial results from period to period and may cause substantial fluctuations period to period.


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The following table indicates the impact of foreign currency fluctuations and changes to our business activities for each of the quarters listed:

                                     2008                             2007                                        2006
(in thousands)                   Q2         Q1         Q4         Q3         Q2        Q1        Q4          Q3          Q2          Q1
Total net sales               $ 12,739   $ 11,847   $ 11,104   $ 10,144   $ 10,315   $ 9,883   $ 8,757     $ 8,540     $ 8,760     $ 8,571
Impact of currency exchange
rate fluctuations (1)              836        674        439        253        267       322       232         135          (1 )      (287 )
Net impact of acquisitions,
distributed sales and
discontinued products,
excluding currency exchange
rate fluctuations (2)              929      1,133      1,116        635        567       455      (252 )      (383 )      (107 )        37

(1) Represents the impact of the change in foreign exchange rates over the corresponding quarter of the prior year based on the weighted average exchange rate for each quarter.

(2) Represents the impact of sales of products of acquired businesses and distributed sales of other manufacturers' products, net of sales related to discontinued products and other activities, based on 12 months' sales following the date of the event or transaction, and shown in the current period only.


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Results of Operations

Comparison of the three and six months ended June 30, 2008, to the three and six months ended June 30, 2007

The following table sets forth, for the periods indicated, our results of operations, net sales by product category, net sales by geography, and the change between the specified periods expressed as a percent increase or decrease:

                                              Three months ended June 30              Six months ended June 30
                                                                     Percent                                Percent
                                            2008          2007       change         2008         2007       change
                                                   ($ in thousands)                       ($ in thousands)
Net sales                                 $  12,739     $ 10,315          23 %    $ 24,586     $ 20,198          22 %
Cost of sales                                 3,853        2,702          43 %       7,211        5,215          38 %

Gross profit                                  8,886        7,613          17 %      17,375       14,983          16 %
Operating expenses:
Sales and marketing                           5,153        4,737           9 %      10,981        9,548          15 %
General and administrative                    2,733        2,206          24 %       5,561        4,576          22 %
Research and development                      1,474        1,118          32 %       2,824        2,272          24 %
Restructuring charges (credits)                 347           (1 )         *           980            5           *
Impairment charge                                48           -            *           483            7           *

Loss from operations                           (869 )       (447 )        94 %      (3,454 )     (1,425 )       142 %
Other income (expense):
Interest income                                 120          344         (65 )%        298          697         (57 )%
Interest expense                                (16 )         -            *           (32 )         (1 )      3100 %
Foreign currency gains                           19           34         (44 )%        166           61         172 %
Other expense, net                               (5 )         (6 )       (17 )%         (2 )         (8 )       (75 )%

Loss before income taxes                       (751 )        (75 )       901 %      (3,024 )       (676 )       347 %
Provision (benefit) for income taxes            175         (302 )      (158 )%        465         (274 )      (270 )%

Net income (loss)                         $    (926 )   $    227        (508 )%   $ (3,489 )   $   (402 )       768 %

Net sales by product category:
Endovascular & Dialysis Access            $   4,328     $  3,672          18 %    $  7,870     $  7,045          12 %
Vascular                                      7,290        5,660          29 %      14,613       11,234          30 %
General Surgery                               1,022          983           4 %       1,926        1,919           0 %

                                             12,640       10,315          23 %      24,409       20,198          21 %
OEM                                              99           -            *           177           -            *

Total                                     $  12,739     $ 10,315          23 %    $ 24,586     $ 20,198          22 %

Net sales by geography:
United States and Canada                  $   6,802     $  6,074          12 %    $ 13,256     $ 11,996          11 %
Outside the United States and Canada          5,937        4,241          40 %      11,330        8,202          38 %

Total                                     $  12,739     $ 10,315          23 %    $ 24,586     $ 20,198          22 %

* Not a meaningful percentage relationship.

Net sales. Net sales increased 23% to $12.7 million for the three months ended and 22% to $24.6 million for the six months ended June 30, 2008 compared to $10.3 million and $20.2 million for the three and six months ended June 30, 2007, respectively. Sales growth was driven by the positive effects of currency exchange rate fluctuations, the inclusion of sales of Biomateriali products and EndoRE Devices, each acquired in the second half of 2007 and not sold by the Company during the prior periods, as well as greater sales of the Powerlink System,


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higher average selling prices across nearly all product lines, and increased sales of the Expandable LeMaitre Valvulotome. Sales growth was offset primarily by comparatively weak sales in Italy during the three months ended March 31, 2008, as we transitioned our sales channel from an independent distributor to a direct sales organization and the distributor sold out its remaining inventory. We believe this issue to be resolved, though there can be no assurance that we will be successful in building an effective Italian sales organization. To a lesser extent, sales were also offset by customer satisfaction issues during the initial launch of our new TT Introducer System.

For the three months ended June 30, 2008 sales in our endovascular and dialysis access product category increased by 18%, sales in our vascular product category increased by 29%, and sales in our general surgery category increased by 4% over the same period in the previous year, and for the six months ended June 30, 2008, sales in our endovascular and dialysis access product category increased by 12%, sales in our vascular product category increased by 30%, and sales in our general surgery category were unchanged over the same period in the previous year. The strong performance of the vascular category reflects in part the addition of our recently acquired products. Direct-to-hospital net sales were 88% of total net sales for both the three months ended June 30, 2008 and the three months ended June 30, 2007. Direct-to-hospital net sales were 87% of total net sales for the six months ended June 30, 2008, as compared to 88% for the six months ended June 30, 2007. In both periods, the effects of our new direct sales initiatives in France, Italy and Ireland were offset by the inclusion of Albograft Vascular Graft sales to an exclusive distributor.

The impact of foreign currency fluctuations and changes in business activities are listed in the table in the Overview Section above.

Net sales by geography. Net sales in the United States and Canada increased 12% to $6.8 million for the three months ended and 11% to $13.3 for the six months ended June 30, 2008, compared to $6.1 million and $12.0 million for the three and six months ended June 30, 2007, respectively. This increase was largely a result of the inclusion of the recently acquired EndoRE Devices, higher average selling prices across nearly all product lines, strong Expandable LeMaitre Valvulotome sales, and increased sales representative efficiency. Net sales outside the United States and Canada increased 40% to $5.9 million for the three months ended and 38% to $11.3 million for the six months ended June 30, 2008, compared to $4.2 million and $8.2 million for the three and six months ended June 30, 2007, respectively. This increase was attributable to the positive effects of currency exchange rate fluctuations, the inclusion of sales of the recently acquired Biomateriali products, increased sales of the Powerlink System, increased sales of the UniFit Abdominal Stent Graft, and increased sales of the Expandable LeMaitre Valvulotome, and was offset primarily by comparatively weak sales in Italy during the three months ended March 31, 2008, as well as customer satisfaction issues during the initial launch of our new TT Introducer System. Outside the United States and Canada, direct-to-hospital net sales represented 74% and 71% of the total net sales for the three and six months ended June 30, 2008, compared to 71% for both the three and six months ended June 30, 2007. In both periods, the direct-to-hospital effects of our new direct sales initiatives in France, Italy and Ireland were offset by the inclusion of Albograft Vascular Graft sales to an exclusive distributor.

Gross profit. Gross profit increased 17% to $8.9 million for the three months ended and 16% to $17.4 million for the six months ended June 30, 2008, from $7.6 million and $15.0 million for the three and six months ended June 30, 2007, respectively. The increase in gross profit was primarily driven by higher net sales, as discussed above. As a percentage of net sales, gross profit was 69.8% compared to 73.8% for the three months ended and 70.7% compared to 74.2% for the six months ended in the comparable periods in the prior year. The decrease in gross margin was primarily due to the inclusion of comparatively lower margin sales by our Biomateriali subsidiary, which we acquired in December 2007, increased sales of the Powerlink System, which we distribute for a third party at comparatively lower gross margins, and increased unit manufacturing costs in our Burlington, Massachusetts headquarters as we slowed production. This decline was partially offset by higher average selling prices across nearly all product lines.

Sales and marketing. Sales and marketing expenses increased 9% to $5.2 million for the three months ended and 15% to $11.0 million for the six months ended June 30, 2008, from $4.7 million and $9.5 million for the three and six months ended June 30, 2007, respectively. This change for the six months ended June 30, 2008 was driven primarily by the increase in the size of our European sales organization as a result of the start-up of our French and Italian sales efforts of $1.0 million and foreign currency exchange rate fluctuations $0.6 million. These factors were the primary drivers for the change in the results for the three months ended June 30, 2008. As of June 30, 2008, we employed 50 sales representatives and 10 sales managers worldwide as compared to 48 sales representatives and 14 sales managers worldwide as of June 30, 2007.


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General and administrative. General and administrative expense increased 24% to $2.7 million for the three months and 22% to $5.6 million for the six months ended June 30, 2008, from $2.2 million and $4.6 million for the three and six months ended June 30, 2007. The increase for the six months ended June 30, 2008 was driven primarily by the inclusion of our Biomateriali, French, and Italian subsidiaries of $0.4 million, the negative effects of currency exchange rate fluctuations on the general and administrative expenses of $0.2 million, and increased audit fees. These factors were the primary drivers for the change in the results for the three months ended June 30, 2008.

Research and development. Research and development expenses increased 32% to $1.5 million for the three months ended and 24% to $2.8 million for the six months ended June 30, 2008, from $1.1 million and $2.3 million for the three and six months ended June 30, 2007, respectively. The increase primarily reflected the increased expense of the UNITE Trial, which did not commence patient enrollment until June 2007, as well as other increased clinical and regulatory spending, as we seek to obtain clearances to sell new or existing products in new markets. We anticipate that research and development expenses will continue to increase as newer UNITE Trial centers commence patient enrollment and new products efforts undergo applicable testing regimes.

Restructuring. Restructuring expenses increased to approximately $0.3 million for the three months and $1.0 million for the six months ended June 30, 2008, compared to a $1,000 restructuring credit and a $5,000 expense in the comparable periods in the prior year. The increase was due to payments related to non-compete and consulting agreements made with our recently terminated Italian distributor of approximately $0.6 million, as well as, severance costs of $0.4 million resulting from the reduction in force of 32 employees in the first quarter.

Impairment charge. In January 2008, we were notified by one of our Biomateriali customers that they would no longer purchase a certain product line from us. As a result, we recorded an impairment charge of $0.4 million to write-down intangible assets related to that customer relationship in the quarter ended March 31, 2008. In June 2008, we recognized an impairment charge of $48,000 related to patents which were deemed to have no value based upon a lack of future expected economic benefits.

Interest income. Interest income was $0.1 million for the three months and $0.3 million for the six months ended June 30, 2008, compared to $0.3 million and $0.7 million for the three and six months ended June 30, 2007, due to lower average cash balances in the quarter and year-to-date periods.

Interest expense. Interest expense increased to $16,000 for the three months ended and $32,000 for the six months ended June 30, 2008, from $0 and $1,000 in the comparable periods in the prior year, primarily due to interest expense related to deferred Biomateriali acquisition payments.

Foreign exchange gains. Foreign exchange gains were $19,000 for the three months ended and $166,000 for the six months ended June 30, 2008, compared to $34,000 and $61,000 in the comparable periods in the prior year due to the comparatively . . .

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